1.1. Adults

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Direct acting antivirals (DAA) for hepatitis are FDA-indicated for treatment of chronic infections caused by hepatitis C virus (HCV). Individual agents have varying FDA indications and treatment durations based on genotype (1-6), subtype (1a vs. 1b), liver function, HIV co-infection and/or previous treatment history¹.

Table 1 provides DAA information for treatment naïve patients with or without cirrhosis.

Table 1: DAAs for treatment of adult chronic HCV infection: Treatment naïve and patients with or without cirrhosis^2-12
Drug Name	Dosage Form/Strength	Treatment Indication	Duration and Coadministration	Maximum Recommended Dosage
elbasvir/ grazoprevir (Zepatier)	50 mg/100 mg tablet	Chronic HCV treatment: genotypes 1a without cirrhosis or with compensated cirrhosis (Child-Pugh A) with baseline NS5A polymorphisms	16 weeks with ribavirin	50 mg elbasvir and 100 mg grazoprevir once daily
		without cirrhosis or with compensated cirrhosis (Child-Pugh A) without baseline NS5A polymorphisms	12 weeks
		genotype 1b without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks
		genotype 4 without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks
glecaprevir/pibrentasvir (Mavyret)	100 mg/40 mg tablets	Chronic HCV treatment: genotypes 1, 2, 3, 4, 5, and 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A)	8 weeks	three tablets once daily (300 mg glecaprevir and 120 mg pibrentasvir)
ledipasvir/ sofosbuvir (Harvoni, generics)	90 mg/400 mg tablet	Chronic HCV treatment: genotype 1 without cirrhosis	8* weeks or 12 weeks	90 mg ledipasvir and 400 mg sofosbuvir once daily
		with compensated cirrhosis (Child-Pugh A)	12 weeks
		decompensated cirrhosis (Child-Pugh B and C)	12 weeks plus ribavirin
		liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin
		genotype 4 liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin
		genotypes 4, 5, or 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks
sofosbuvir/ velpatasvir (Epclusa, generics)	400 mg/100 mg tablets	Chronic HCV treatment: genotypes 1, 2, 3, 4, 5, and 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks	400 mg sofosbuvir and 100 mg velpatasvir once daily
		genotypes 1, 2, 3, 4, 5, and 6 with decompensated cirrhosis (Child-Pugh B or C)	12 weeks plus ribavirin
sofosbuvir (Sovaldi)	400 mg tablet	Chronic HCV treatment: genotypes 1 and 4 without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin and peginterferon	400 mg once daily
		genotype 2 without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin
		genotype 3 without cirrhosis or with compensated cirrhosis (Child-Pugh A)	24 weeks plus ribavirin

Legend:

HCV = hepatitis C virus;
NS5A inhibitors = Nonstructural protein 5A (NS5A) inhibitors
NS3/4A protease inhibitors = Nonstructural protein 3/4A protease inhibitors
* = 8 weeks of treatment can be considered in treatment naïve genotype 1 patients without cirrhosis who have pretreatment HCV RNA less than 6 million IU/mL

Table 2: DAAs for treatment of adult chronic HCV Infection: Treatment experienced patients with or without cirrhosis^2-12
Drug Name	Dosage Form/Strength	Treatment Indication	Duration and Coadministration	Maximum Recommended Dosage
elbasvir/grazoprevir (Zepatier)	50 mg/100 mg tablet	Chronic HCV treatment: genotypes 1a: that is peginterferon alfa/ribavirin experienced without baseline NS5A polymorphisms without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks	50 mg elbasvir and 100 mg grazoprevir once daily
		that is peginterferon alfa/ribavirin experienced with baseline NS5A polymorphisms without cirrhosis or with compensated cirrhosis (Child-Pugh A)	16 weeks plus ribavirin
		that is peginterferon alfa/ribavirin and/or NS3/4A protease experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin
		genotype 1b: that is peginterferon alfa/ribavirin experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks
		that is peginterferon alfa/ribavirin and/or NS3/4A protease experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin
		genotype 4 that is peginterferon alfa/ribavirin experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A)	16 weeks plus ribavirin
glecaprevir/ pibrentasvir (Mavyret)	100 mg/40 mg tablets	Chronic HCV treatment: genotype 1 who have previously been treated with a regimen containing an HCV NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor with or without compensated cirrhosis (Child-Pugh A)	16 weeks	three tablets once daily (300 mg glecaprevir and 120 mg pibrentasvir)
		who have previously been treated with a regimen containing an NS3/4A protease inhibitor without prior treatment with a NS5A inhibitor with or without compensated cirrhosis (Child-Pugh A)	12 weeks
		genotypes 1,2, 4, 5, or 6 with prior treatment with a peg interferon, ribavirin and/or sofosbuvir, but no prior treatment with an NS3/4A PI or NS5A inhibitor without cirrhosis	8 weeks
		genotypes 1,2, 4, 5, or 6 with prior treatment with a peg interferon, ribavirin and/or sofosbuvir, but no prior treatment with an NS3/4A PI or NS5A inhibitor with compensated cirrhosis (Child-Pugh A)	12 weeks
		genotype 3 with prior treatment with a peg interferon, ribavirin and/or sofosbuvir, but no prior treatment with an NS3/4A PI or NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A)	16 weeks
ledipasvir/sofosbuvir (Harvoni, generics)	90 mg/400 mg tablet	Chronic HCV treatment: genotype 1 who have failed peginterferon alfa or ribavirin-based regimen with or without a protease inhibitor without cirrhosis	12 weeks	90 mg ledipasvir and 400 mg sofosbuvir once daily
		with compensated cirrhosis (Child-Pugh A)	24 weeks or 12 weeks in combination with ribavirin†
		decompensated cirrhosis (Child-Pugh B or C) plus ribavirin	12 weeks plus ribavirin
		liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin
		genotype 4 who have failed peginterferon alfa or ribavirin-based regimen with or without a protease inhibitor in liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin
		genotype 4, 5, or 6 without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have failed peginterferon alfa and/or ribavirin-based regimen with or without a protease inhibitor	12 weeks
sofosbuvir/velpatasvir (Epclusa, generics)	400 mg/100 mg tablets	Chronic HCV treatment: genotype 1, 2, 3, 4, 5, or 6 treated with peginterferon/ribavirin and/or NS3/4A protease inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks	400 mg sofosbuvir and 100 mg velpatasvir once daily
		with decompensated cirrhosis (Child-Pugh B or C)	12 weeks plus ribavirin
sofosbuvir (Sovaldi)	400 mg tablet	Chronic HCV treatment: genotype 2 previously treated with an interferon-based regimen without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks plus ribavirin	400 mg once daily
		genotypes 1a or 3 previously treated with sofosbuvir without a NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A)	24 weeks plus ribavirin
sofosbuvir, velpatasvir, and voxilaprevir (Vosevi)	400 mg/100 mg/100 mg	Chronic HCV treatment: genotypes 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A)	12 weeks	400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir once daily
		genotypes 1a or 3 previously treated with sofosbuvir without a NS5A inhibitor	12 weeks

Legend:

HCV = hepatitis C virus
NS5A inhibitors = Nonstructural protein 5A (NS5A) inhibitors
NS3/4A protease inhibitors = Nonstructural protein 3/4A protease inhibitors
∆ NS5A resistance-associated polymorphisms at amino acid positions 28, 30, 31, or 93. Testing prior to the initiation of therapy, subsection NS5A resistance testing in HCV genotype 1a-infected patients
£ The optimal ZEPATIER-based treatment regimen and duration of therapy for PegIFN/RBV/PI-experienced genotype 1a-infected patients with one or more baseline NS5A resistance-associated polymorphisms at positions 28, 30, 31, and 93 has not been established
†Harvoni + ribavirin for 12 weeks can be considered in treatment-experienced genotype 1 patients with cirrhosis who are eligible for ribavirin